A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old

Last updated: November 11, 2024
Sponsor: Takeda
Overall Status: Active - Recruiting

Phase

2

Condition

Gastroesophageal Reflux Disease (Gerd)

Gastroparesis

Esophageal Disorders

Treatment

Dexlansoprazole

Clinical Study ID

NCT02616302
TAK-390MR_204
U1111-1166-8748
2014-004506-15
2022-501349-64
  • Ages 2-11
  • All Genders

Study Summary

Gastroesophageal reflux disease (GERD) is caused by food or acid coming up from the stomach into the esophagus, repeatedly. The esophagus is the tube that carries food and liquids from the mouth to the stomach.

The body uses stomach acid to break down food, but when acid rises up into the esophagus it can hurt or damage it. People with GERD often feel food coming back up into the throat and mouth and have a burning feeling in their stomach, chest, or throat, called heartburn. Other symptoms of GERD include pain in the stomach or throat, difficulty eating, and throwing up. Symptomatic nonerosive GERD is a condition where people have the symptoms of GERD but the esophagus has not been damaged. People of all ages can have GERD. The causes of GERD in children are similar to those in adults and teenagers.

Dexlansoprazole is a medicine that has been shown to help relieve the symptoms of GERD in adults and teenagers. This study aims to find out if dexlansoprazole doses given to children with symptomatic nonerosive GERD, based on their body weight, helps them feel better.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. In the opinion of the investigator, the participant (as age appropriate) and/orparent(s)/legal guardian is capable of understanding and complying with protocolrequirements.

  2. Prior to any study-specific procedures being performed, the appropriate informedconsent and the assent form(s) (as applicable) must be signed and dated by parent(s)or legal guardian and by the participant respectively, if appropriate.

  3. Has a medical history of symptoms of GERD for at least 3 months prior to Screening.

  4. Has met the eDiary qualification criteria as assessed by the PGSDD, defined ashurting or burning in the stomach, chest, or throat on at least 3 of any 7consecutive days during the Screening Period.

  5. Has no evidence of erosive esophagitis (EE) according to the Los Angeles (LA)Classification of Esophagitis and, in the investigator's clinical judgment, thesymptoms are suggestive of acid-related disease. A 24-hour pH-metry (with or withoutimpedance) may be performed during Screening or within 6 months prior to Screeningfor similar symptoms as those identified during Screening if, in the investigator'sjudgment, this procedure would aid in the determination of whether the participant'ssymptoms are acid-related. An endoscopy performed within 1 week prior to signingscreening informed consent and assent form (as applicable) is an acceptablereplacement for the screening endoscopy if nonerosive GERD is confirmed,protocol-required biopsies were collected, and endoscopic pictures were obtained.

  6. Is male or female and age 2 to 11 years, inclusive, at the time of screeninginformed consent.

Exclusion

Exclusion Criteria:

  1. Has evidence of cardiovascular, pulmonary, central nervous system, hepatic,hematopoietic, renal, or metabolic disorder, severe allergy, asthma, or allergicskin rash that suggests any uncontrolled, clinically significant underlying diseaseor condition (other than the disease being studied), which may impact the ability ofthe participant to participate or potentially confound the study results.

  2. Has a coexisting disease affecting the esophagus (eg, esophageal varices,scleroderma, viral or fungal infection, or esophageal stricture), history ofradiation therapy or cryotherapy to the esophagus, caustic or physiochemical traumasuch as sclerotherapy to the esophagus.

  3. Has any findings in his/her medical history, physical examination, or safetyclinical laboratory tests giving reasonable suspicion of underlying disease thatmight interfere with the conduct of the trial.

  4. Has a history of hypersensitivity or allergies to dexlansoprazole or any componentof the formulation of dexlansoprazole capsules, or any proton pump inhibitor (PPI) (including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole) orantacids.

  5. Is required to take excluded medications or it is anticipated that the participantwill require treatment with at least 1 of the disallowed concomitant medicationsduring the study evaluation period.

  6. Has a condition that may require inpatient surgery during the course of the study.

  7. Has a known history of Barrett's esophagus with dysplastic changes in the esophagus.

  8. Has a known history of eosinophilic esophagitis (EoE) or histologic findingssuggestive of EoE (≥15 eosinophils per high-powered field [HPF]).

  9. Has history of celiac disease, tests positive for tissue transglutaminase (tTG),antibody or confirmed disease by histology.

  10. Has history of inflammatory bowel disease, or irritable bowel syndrome.

  11. Has active gastric or duodenal ulcers within 4 weeks prior to Day -1. If present >4weeks prior to Day -1, ulcers must not be present upon screening endoscopy.

  12. Requires dilatation of esophageal strictures and/or strictures preventing passage ofthe endoscope during the screening endoscopy. Schatzki's ring (a ring of mucosaltissue near the lower esophageal sphincter) is acceptable.

  13. A female participant who has reached menarche by Day -1.

  14. Is known to be positive for the human immunodeficiency virus (HIV).

  15. Has current or historical evidence of Zollinger-Ellison syndrome or otherhypersecretory condition.

  16. Has a history of gastric, duodenal, or esophageal surgery except simple oversew ofan ulcer. A history of gastric tube and/or percutaneous endoscopic gastrostomy (PEG)placement is allowed.

  17. Had an acute upper gastrointestinal hemorrhage within 4 weeks prior to endoscopy.

  18. Has donated or lost >10% of the total blood volume, undergone plasmapheresis, or hashad a transfusion of any blood product within 90 days prior to the first dose ofstudy drug.

  19. Has a known history of alcohol abuse or illegal drug use within the past 12 monthsprior to the first dose of study drug.

  20. Has any screening abnormal laboratory value that suggests a clinically significantunderlying disease or condition that may prevent the participant from entering thestudy; or the participant has: creatinine >1.5 mg/dL, alanine aminotransferase (ALT)and/or aspartate aminotransferase (AST) >2 times the upper limit of normal (×ULN),or total bilirubin >2.0 milligrams per deciliter (mg/dL) with AST/ALT elevated abovethe limits of normal values.

  21. Is an immediate family member, study site employee, or is in a dependentrelationship with a study site employee who is involved in the conduct of this studyor may consent and assent (as applicable) under duress. Students of theinstitution/research facility who are under the supervision of, or in a subordinaterole to, the investigator are also ineligible.

  22. The participant, in the opinion of the investigator, is unlikely to comply with theprotocol or is unsuitable for any other reason.

  23. Has participated in another clinical study (not including screening for StudyTAK-390MR_205 [NCT02615184]) and/or has received any investigational compound within 30 days prior to Screening.

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Dexlansoprazole
Phase: 2
Study Start date:
February 20, 2023
Estimated Completion Date:
October 31, 2027

Study Description

The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to treat children aged 2 to 11 years who have nonerosive GERD. This study will look at the effectiveness and side effects of three different doses of dexlansoprazole in children with GERD.

The study will enroll approximately 70 patients. Participants weighing ≤30 kilograms (kg) will be randomly assigned (by chance, like flipping a coin) to receive dexlansoprazole 15 or 30 milligrams (mg), and participants who weigh >30 kg will be randomized to receive dexlansoprazole 30 or 60 mg.

All participants will be asked to take one capsule at the same time each day throughout the study. Parents/caregivers for participants ages 2 to 8 and participants ages 9 to 11 will be asked to record any time they have heartburn symptoms in an electronic diary.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 16 weeks, which includes up to 4 weeks to screen for the study. Participants will make multiple visits to the clinic, plus a final phone call 5 to 10 days after last dose of study drug for a follow-up assessment.

Connect with a study center

  • empty

    Bruxelles,
    Belgium

    Site Not Available

  • empty

    Montegnee,
    Belgium

    Site Not Available

  • empty

    Passo Fundo, Rio Grande do Sul
    Brazil

    Site Not Available

  • empty

    Sao Paulo,
    Brazil

    Site Not Available

  • Women and Children's Health Research Institute

    Edmonton, Alberta T6G 1C9
    Canada

    Site Not Available

  • London Health Sciences Centre (LHSC) - Children's Hospital

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • Hospital Universitario San Ignacio

    Bogota, 110231
    Colombia

    Site Not Available

  • Centro Medico Imbanaco de Cali S.A

    Cali, 760042
    Colombia

    Site Not Available

  • Fundacion Valle del Lili

    Cali, 760032
    Colombia

    Site Not Available

  • empty

    Afula,
    Israel

    Site Not Available

  • empty

    Beer Sheva,
    Israel

    Site Not Available

  • empty

    Beer Yaakov,
    Israel

    Site Not Available

  • empty

    Haifa,
    Israel

    Site Not Available

  • empty

    Jerusalem,
    Israel

    Site Not Available

  • empty

    Ramat Gan,
    Israel

    Site Not Available

  • empty

    Tiberias,
    Israel

    Site Not Available

  • empty

    Napoli,
    Italy

    Site Not Available

  • empty

    Roma,
    Italy

    Site Not Available

  • Hospital of Lithuanian University of Health Sciences Kauno Klinikos

    Kaunas, LT-50161
    Lithuania

    Active - Recruiting

  • Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos, Public Institution

    Vilnius, LT-08661
    Lithuania

    Active - Recruiting

  • Boca Clinical Trials Mexico SC

    Colonia Las Americas, Distrito Federal 1120
    Mexico

    Site Not Available

  • empty

    Mexico, Distrito Federal
    Mexico

    Site Not Available

  • Clinical Research Institute S.C.

    Tlalnepantla, Estado De Mexico 54055
    Mexico

    Active - Recruiting

  • empty

    Morelia, Michoacan
    Mexico

    Site Not Available

  • Inspirepharma S. de R.L. de C.V.

    Monterrey, Nuevo Leon 64660
    Mexico

    Site Not Available

  • El Cielo Medical Center

    Puebla, 72160
    Mexico

    Active - Recruiting

  • SMIQ S. de R.L. de C.V.

    Queretaro, 76070
    Mexico

    Active - Recruiting

  • empty

    Veracruz,
    Mexico

    Site Not Available

  • In Vivo Osrodek Badan Klinicznych

    Bydgoszcz, Kuyavia 85-048
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    Krakow, Malopolskie 30-663
    Poland

    Site Not Available

  • Instytut "Pomnik - Centrum Zdrowia Dziecka"

    Warszawa, Masovia 04-730
    Poland

    Site Not Available

  • Gabinet Lekarski Bartosz Korczowski

    Rzeszow, Podkarpackie 35-302
    Poland

    Active - Recruiting

  • empty

    Worclaw,
    Poland

    Site Not Available

  • empty

    Braga,
    Portugal

    Site Not Available

  • empty

    Coimbra,
    Portugal

    Site Not Available

  • empty

    Lisboa,
    Portugal

    Site Not Available

  • empty

    Porto,
    Portugal

    Site Not Available

  • University of South Alabama

    Mobile, Alabama 36604
    United States

    Active - Recruiting

  • empty

    Phoenix, Arizona
    United States

    Site Not Available

  • empty

    Tucson, Arizona
    United States

    Site Not Available

  • empty

    Los Angeles, California
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94158
    United States

    Site Not Available

  • D&H National Research Centers

    Miami, Florida 33155
    United States

    Active - Recruiting

  • Children's Center for Digestive Health Care, LLC

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • empty

    Chicago, Illinois
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • empty

    Shreveport, Louisiana
    United States

    Site Not Available

  • Gastrointestinal Associates, PA

    Flowood, Mississippi 39232
    United States

    Active - Recruiting

  • empty

    Jackson, Mississippi
    United States

    Site Not Available

  • empty

    Kansas City, Missouri
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • empty

    Toledo, Ohio
    United States

    Site Not Available

  • Measurable Outcome Research

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • GI for Kids

    Knoxville, Tennessee 37922
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • empty

    Fort Worth, Texas
    United States

    Site Not Available

  • empty

    Houston, Texas
    United States

    Site Not Available

  • Envision Clinical Research, LLC

    Laredo, Texas 78041
    United States

    Active - Recruiting

  • empty

    Salt Lake City, Utah
    United States

    Site Not Available

  • The Children's Hospital of The King's Daughters

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

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